Gastrostomy feeding devices connect the stomach to the exterior of the body through a stoma site. These devices are inserted and left in for the period of time that access to the stomach is needed, and are used as a conduit for feeding, decompression, delivery of medications, and suctioning of fluids. Gastrostomy feeding ports may rise just above the skin level, or they may be an extended tube-like structure with adapters on the exterior end. In either case, an external bolster is used to hold the tube in place to prevent slippage of the external portion of the tube into the stomach.
Bolsters in the prior art not only provide a mechanism to hold the tube to prevent tube slippage, but also in the tubes that rise just slightly above the skin, these bolsters are charged with connecting to the feeding delivery sets, or syringes used to access the gastrostomy. In this case, a part of the bolster must connect the lumen that traverses the stoma into the stomach with the feeding set or syringe. When this connection is opened, reflux of gastric contents is likely.
Prevention of the leakage of gastric contents and the control of gastric pressures in an acidic environment has become a significant design challenge. Materials must be resilient, soft and resealable over time. Unfortunately, many of the gastrostomy feeding port valves or mechanisms for reflux prevention have failed over time, especially after repeated uses.
Valves have been used as a mechanism to block the unwanted flow of gastric contents outward. The prior art includes check valves, such as those available commercially by Novartis under Russo, U.S. Pat. No. 4,944,732. This product offers a replacement valve which may be screwed into place. The Button, another commercially available device, offers an external rubber flip cap and a tongue valve placed in the stomach end of the communicating lumen. Over time, both the rubber flip cap and the tongue valve become embrittled, and will fail to function.
Copenhaver, et al. U.S. Pat. No. 5,720,734, commercially available as the Passport from Wilson-Cook Medical, Inc., discusses an “s” slit valve, which lies under compression in a rigid plastic lumen. Because it is a rubber valve, it is fraught with the same embrittlement issues, especially after being violated multiple times per day over a long period.
Prior art devices are formed of rigid plastic and fit only feeding delivery set tips and use an adapter to fit the bolus syringe tips, or have been soft rubber or plastic and subject to breakage upon repeated usage. There is a need for a long term indwelling gastrostomy feeding port which does not utilize a soft rubber valve system or soft rubber flip caps, but which serves to control flow to and from the stomach. This required device eliminates the need for rubber valves and rubber flip caps.